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A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00300287
First received: March 6, 2006
Last updated: July 16, 2007
Last verified: July 2007
History of Changes
  Purpose

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Vildagliptin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in HbA1c at 108 weeks

Secondary Outcome Measures:
  • Adverse event profile after 108 weeks of treatment
  • Change in HbA1c from week 52 to week 108
  • Change from baseline in fasting plasma glucose at week 108
  • Change in fasting plasma glucose from week 52 to week 108
  • Change from baseline in body weight at week 108

Estimated Enrollment: 150
Study Start Date: February 2006
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Completion of study CLAF237A2307 within 4 weeks of entering into the extension
  • Written informed consent
  • Ability to comply with all study requirements
  • Blood glucose criteria must be met

Exclusion Criteria:

  • Premature discontinuation from study CLAF237A2307
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300287

Locations
Germany
Investigative Sites, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00300287     History of Changes
Other Study ID Numbers: CLAF237A2307E1
Study First Received: March 6, 2006
Last Updated: July 16, 2007
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Novartis:
Type 2 diabetes
Vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
 Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013